FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2861041
·
Received December 3, 2012
Report
- Report Number
- 1627487-2012-06846
- Event Type
- Injury
- Date Received
- December 3, 2012
- Date of Event
- November 8, 2012
- Report Date
- November 8, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2012-06847, 06848. THE PT ORIGINALLY HAD TWO LEADS (ONE WAS FOR OFF-LABEL USE). IT WAS REPORTED, THE PT WAS NOT RECEIVING ADEQUATE COVERAGE. AS A RESULT THE PT UNDERWENT A TRIAL PROCEDURE ON (B)(6) 2012 AND RECEIVED AN ADD'L LEAD. ON (B)(6) 2012, THE LEAD FOR OFF-LABEL USE WAS EXPLANTED AND REPLACED. IT IS UNK WHICH OF THE ORIGINALLY IMPLANTED LEADS WAS EXPLANTED. THE PT'S IPG WAS ALSO EXPLANTED AND REPLACED (WITH A DIFFERENT MODEL), BUT THE REASON REMAINS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 45814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention | SCS LEAD: MODEL 3286| IMPLANT: |